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Comparison of B-cell Depletion by Rituximab and Anti-CD 19 CAR-T Therapy in Patients With Rheumatoid Arthritis

Study acronym: COMPARE
StatusActive, Not Recruiting
PhasePhase 1/2
Started2024-12-04
View on ClinicalTrials.gov ↗

Amendment history

2026-03-04
notable
Not Yet Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Active, Not Recruiting
Primary completion date2027-03→2027-06
Completion date2027-03→2027-06
Start dateestimated 2024-11→confirmed 2024-12-04
Study sites0→1
2024-06-25
minor
Original filing
The goal of this phase I/II clinical trial is to compare B-cell depletion by rituximab and anti-CD 19 CAR-T therapy in patients with rheumatoid arthritis. The main questions it aims to answer are: * To assess the safety of anti-CD19 CAR T cell therapy in subjects with active, ACPA positive and treatment refractory RA (Phase-I) * To assess the safety of anti-CD19 CAR T cell therapy and of rituximab in subjects with active, ACPA positive and treatment refractory RA (Phase-II) * To assess ACPA seroconversion after anti-CD19 CAR T cell or rituximab therapy in subjects with active, ACPA positive and treatment refractory RA (Phase-II) Participants in the test-arm will receive a single dose of KYV-101 i.v., an autologous fully-human anti-CD19 CAR T-cell immunotherapy. In the comparator group patients will receive 2x1 g Rituximab i.v. Follow-up time (both arms) is 52 weeks with regular visits at the site.
Trial Details
NCT Number NCT06475495
Lead Sponsor Charite University, Berlin, Germany
Collaborators: Kyverna Therapeutics
Conditions Rheumatoid Arthritis
Enrollment 13 participants
Start Date 2024-12-04
Primary Completion 2027-06 (estimated)
Study Completion 2027-06 (estimated)
Updated on ClinicalTrials.gov 2026-03-05